Job Description
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Join to apply for the Regulatory Affairs Manager role at Viking Therapeutics, Inc.
Job Description/Summary
The Regulatory Affairs Manager (RA Manager) will manage, evaluate, and complete regulatory projects consistent with company goals. The RA Manager is responsible for maintaining the electronic trial master files, reviewing, and overseeing the production of clinical and regulatory documents in support of product development applications.
Essential Duties And Responsibilities
The main Regulatory Affairs responsibilities of this role include but are not limited to the following:
Is responsible for the management and administrative aspects of global regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of the highest quality, and delivered on-time.
Represents Regulatory in cross-functional teams and provide guidance to teams on the regulatory requirements and risk(s) to support clinical development programs including preparation and maintenance of e.g., IND, CTA, and IMPD filings.
Develops, reviews and/or files INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring and managing the development of DSURs, annual reports, CSRs, Protocols, Investigator Brochures, and amendments as needed.
Provides regulatory representation and expertise on cross-functional teams as needed. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs.
Conducts regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams.
Collaborates with and supervises contributions from contractors and vendors.
Develops and manages project timelines for regulatory submissions.
Manages and maintains the electronic trial master files for regulatory, clinical, and non-clinical departments.
Description
REPORTS TO
Vice President, Regulatory Affairs
Job Description/Summary
The Regulatory Affairs Manager (RA Manager) will manage, evaluate, and complete regulatory projects consistent with company goals. The RA Manager is responsible for maintaining the electronic trial master files, reviewing, and overseeing the production of clinical and regulatory documents in support of product development applications.
Essential Duties And Responsibilities
The main Regulatory Affairs responsibilities of this role include but are not limited to the following:
Is responsible for the management and administrative aspects of global regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of the highest quality, and delivered on-time.
Represents Regulatory in cross-functional teams and provide guidance to teams on the regulatory requirements and risk(s) to support clinical development programs including preparation and maintenance of e.g., IND, CTA, and IMPD filings.
Develops, reviews and/or files INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring and managing the development of DSURs, annual reports, CSRs, Protocols, Investigator Brochures, and amendments as needed.
Provides regulatory representation and expertise on cross-functional teams as needed. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs.
Conducts regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams.
Collaborates with and supervises contributions from contractors and vendors.
Develops and manages project timelines for regulatory submissions.
Manages and maintains the electronic trial master files for regulatory, clinical, and non-clinical departments.
Requirements
EDUCATION AND EXPERIENCE REQUIREMENTS
Bachelor's degree in scientific discipline with 2-5 years pharmaceutical industry experience, including 2+ years in Regulatory Affairs.
Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical) including experience with CTD/eCTD.
Working knowledge of GMP, GLP, and GCP regulations as well as an understanding of the pharmaceutical product life cycle.
Working knowledge of FDA and ICH regulatory guidance and regulations.
Working knowledge of ex-US regulatory affairs (EMA, MHRA, PMDA) desirable.
Other duties as needed.
Knowledge And Skills Requirements
High degree of proficiency Microsoft Office Suite (i.e., Word, PowerPoint, etc.), Outlook Internet applications, WebEx, Zoom
High attention to detail and excellent proofreading and editing skills
Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion
Ability to multi-task, professional demeanor, strong attention to detail
Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude
Must be dependable; someone willing to go the extra-mile to get things done
Team player with excellent oral, written and verbal communication skills.
VIKING THERAPEUTICS
Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA
Notice to Agency and Search Firm Representatives
Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Seniority level Seniority level Mid-Senior level
Employment type Employment type Full-time
Job function Job function Legal
Industries Pharmaceutical Manufacturing
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Full time, For contractors, Work at office, Local area, Remote work,